Events

Rappel de Device Recall ActCel Topical Hemostatic Dressing

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Coreva Health Science LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    71279
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1697-2015
  • Date de mise en oeuvre de l'événement
    2015-05-18
  • Date de publication de l'événement
    2015-05-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137216
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Dressing, wound, drug - Product Code FRO
  • Cause
    Coreva health science, llc. is recalling actcel hemostatic dressing due to customer literature and web sites promoting that it can help control bleeding from open wounds and in body cavities. actcel is indicated as a prescription device for management of topical wounds and to temporarily control external surface bleeding.
  • Action
    On 05/18/15 the firm sent out customer notification letters to those distributors that were identified as marketing ActCel Hemostatic Dressing for use to help control bleeding from open wounds in body cavities. The firm's notification letter provided the following actions to be taken by the customer: - Review their literature and labeling (including internet websites) to determine whether there are any marketing statements for usage in body cavities; -Destroy all hardcopy literature and labeling with the statement for usage in body cavities - Correct all Internet websites eliminating his statement; and - Complete the attached Medical Device Labeling Clarification Return Response form and return it to Coreva Health Science. The firm states to direct any questions to: Ms. Casssie Inglis, Vice President of Marketing. email: cassie@coreva.net phone: 818-685-0951 ext. 119 toll free: 800-808-9094 ext. 119 Monday through Friday, 9am-4pm PST

Device

Device Recall ActCel Topical Hemostatic Dressing
  • Modèle / numéro de série
    201303054, 201310418, 201406259, 201409367, 201502051, 201307297, 201310460, 201401023, 201406260, 201409368, 201303054, 201305137, 201401022, 201403096, 201404143
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    U.S. distribution to the following; TX, NY, FL, VA, WA, and AZ. No foreign distribution. NOTE: The distribution list the firm provided does not include all consignees that purchased the product; rather target the consignees (distributors) who were observed to be using an unapproved marketing use.
  • Description du dispositif
    ActCel || advanced bleeding control || Topical Hemostatic Dressing || 2in X 2in (5cm X 5cm) || 4in X 4in || Sterile Contents || Soluble Regenerated Cellulose || For Bleeding Control || For external topical and temporary use only || Sterility of contents guaranteed unless individual envelope is damaged or opened. Store at room temperature (41F-104F). Do not autoclave.
  • Manufacturer
    Coreva Health Science LLC

Manufacturer

Coreva Health Science LLC
  • Adresse du fabricant
    Coreva Health Science LLC, 2985 E Hillcrest Dr Ste 205, Westlake Village CA 91362-3179
  • Société-mère du fabricant (2017)
    Coreva Health Science Llc
  • Source
    USFDA